FDA Approves Increased Dosage for Biofrontera's Ameluz in Actinic Keratosis Treatment

Key Insights

• The FDA has approved Biofrontera's supplemental New Drug Application (sNDA) to allow the use of up to three tubes of Ameluz per photodynamic therapy (PDT) treatment.
• This expanded dosage provides healthcare professionals with greater flexibility in treating larger or multiple areas affected by actinic keratosis (AK) on the face and scalp.
• The approval was supported by Phase I safety studies, which demonstrated that higher doses of Ameluz maintain a safety profile equivalent to that of a single tube.

Biofrontera Inc. (Nasdaq: BFRI) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid HCl) Topical Gel, 10%, allowing for the use of up to three tubes in a single photodynamic therapy (PDT) treatment session. This expanded indication aims to provide healthcare professionals with increased flexibility when addressing extensive or multiple areas affected by actinic keratosis (AK).

Clinical Support for Dosage Increase

The sNDA was backed by data from two Phase I safety studies involving 116 patients. These studies evaluated the safety of applying three tubes of Ameluz and found that blood concentrations of the active ingredient and its metabolite remained significantly below levels associated with known side effects. The systemic and application site adverse events observed were consistent with those seen when using a single tube of Ameluz.

Impact on Treatment of Actinic Keratosis

Actinic keratosis (AK) is a common precancerous skin lesion resulting from chronic sun exposure, with a potential to develop into squamous cell carcinoma if left untreated. In 2020, approximately 58 million people in the U.S. were affected by AK, leading to 13 million treatments. The increased dosage allowance is expected to improve treatment outcomes by enabling more comprehensive coverage of affected areas.

Expert Commentary

"We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz per treatment," stated Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. Dr. Jonathan Weiss, investigator and co-managing partner at Georgia Dermatology Partners, added, "Up to 60% of squamous cell carcinomas begin as untreated AK lesions, so it’s important for us to be able to treat the entire affected field. I have used Ameluz now for more than 7 years for the management of AK because of the demonstrated efficacy and safety it delivers. With the approval of the sNDA, I look forward to being able to use up to three tubes for those patients that need them."

Biofrontera's Focus on PDT

Biofrontera Inc. specializes in dermatological treatments, particularly photodynamic therapy (PDT). Ameluz, in combination with the RhodoLED lamp series, is used for PDT of AK. The company continues to conduct clinical trials to broaden the application of its products to include non-melanoma skin cancers and moderate to severe acne.